Saada 1997.
Study characteristics | |||
Patient Sampling | From July 1993 to December 1994, 50 patients underwent a first elective orthotopic liver transplantation (OLT) at our centre for end‐stage chronic liver disease and were included in this study. Preoperative imaging included hepatic ultrasonography (ATL, Ultramark 9) and CT (Somatom DR2, Siemens, Erlangen, Germany) consisting of 1 cm contiguous sections through the entire liver, prior to and after 75 mL of intravenous contrast agent. Of the 50 cases considered for inclusion, there were protocol violations in 11 due to a donor liver becoming available after Lipiodol administration but prior to iodised oil computed tomography (IOCT) examination. Complete pre‐OLT imaging was available in the remaining 39 patients (14 women, 25 men). Age range not reported. Males 64% |
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Patient characteristics and setting | |||
Index tests | Abdomnal US (ATL, Ultramark 9), no definition of positivity criteria | ||
Target condition and reference standard(s) | Following transplantation the explant liver was cut into 10 mm slices. Each slice was closely inspected for atypical nodules according to a standard protocol. | ||
Flow and timing | The median time between iodised oil computed tomography (IOCT) and orthotopic liver transplantation (OLT) was 20 days (range 10 days – 80 days). | ||
Comparative | |||
Notes | |||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | No | ||
Could the selection of patients have introduced bias? | High risk | ||
Are there concerns that the included patients and setting do not match the review question? | High | ||
DOMAIN 2: Index Test (AFP) | |||
DOMAIN 2: Index Test (US+AFP) | |||
DOMAIN 2: Index Test (US) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | No | ||
Could the conduct or interpretation of the index test have introduced bias? | High risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Low concern | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | No | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | High risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |